Differential Rate Kinetic Method, Cpk Or Isoenzymes
FDA product code JHS · Class II (moderate risk) · 21 CFR 862.1215 · Clinical Chemistry
38510(k) clearances
0PMA approvals
11recalls
Manufacturers
- Smithkline Diagnostics, Inc. 4
- Careside, Inc. 2
- Fisher Scientific Co., LLC 2
- Dupont Medical Products 2
- Worthington Diagnostic Systems 2
- Eastman Kodak Company 2
- Intl. Immunoassay Laboratories, Inc. 2
- Pointe Scientific, Inc., 1
- Roche Diagnostics Operations (Rdo) 1
- Baxter Healthcare Corp 1
- Sclavo, Inc. 1
- Technostics Intl. 1
- Coulter Electronics, Inc. 1
- Biorent Diagnostic, Inc. 1
- Gamma Enterprises, Inc. 1
- Harleco 1
- Biodynamics Corp. 1
- Laboratory Diagnostics Co., Inc. 1
- Data Medical Associates, Inc. 1
- E.I. Dupont DE Nemours & Co., Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K160570 | Creatine KinaseJHS · Traditional | Roche Diagnostics Operations (Rdo) | 05/25/2016SE |
| K102706 | CKMB Udr AssayJHS · Traditional | SENTINEL CH. SpA | 08/19/2011SE |
| K082226 | S40 Creatine Kinase (CK)JHS · Traditional | Alfa Wassermann Diagnostic Technologies, Inc. | 09/18/2008SE |
| K062128 | The Dimension Vista Flex Reagent Cartridges / Kit AssaysJHS · Special | Dade Behring, Inc. | 08/21/2006SE |
| K990439 | Careside CKJHS · Traditional | Careside, Inc. | 04/19/1999SE |
| K990434 | Careside CKMBJHS · Traditional | Careside, Inc. | 04/19/1999SE |
| K981495 | Immulite Ck-Mb, Catalog # LKCP1 (100 Tests), LKCP5 (500 Tests)JHS · Traditional | Diagnostic Products Corp. | 06/10/1998SE |
| K962126 | Acs CKMB II ImmunoassayJHS · Traditional | Ciba Corning Diagnostics Corp. | 06/21/1996SE |
| K952250 | Stratus Ck-Mb Dendrimer Fluorometric Enzyme Immunoassay & Stratus Ck-Mb Dendrimer High…JHS · Traditional | Dade Intl., Inc. | 07/17/1995SE |
| K945083 | Access Ck-Mb ReagentsJHS · Traditional | Bio-Rad Laboratories, Inc. | 11/21/1994SE |
| K943024 | Kinase IsoenzymeJHS · Traditional | Dupont Medical Products | 08/02/1994SE |
| K941584 | Creatine Kinase MethodJHS · Traditional | Dupont Medical Products | 07/06/1994SE |
| K903025 | Roche Isomune- CKJHS · Traditional | Roche Diagnostic Systems, Inc. | 08/09/1990SE |
| K900806 | Stratus(R) Ck-Mb Fluorometric Enzyme ImmunoassayJHS · Traditional | Baxter Healthcare Corp | 03/23/1990SE |
| K883223 | Check-MmJHS · Traditional | Intl. Immunoassay Laboratories, Inc. | 09/30/1988SE |
| K872029 | Uni-Fast Creatine Kinase Test (CK)JHS · Traditional | Sclavo, Inc. | 06/17/1987SE |
| K861387 | Kodak Ektachem Clinical Chemistry Slides (Ck-Mb)JHS · Traditional | Eastman Kodak Company | 06/27/1986SE |
| K855188 | CPK (UV) Reagent KitJHS · Traditional | Technostics Intl. | 03/05/1986SE |
| K854708 | Dart Ck-Mb Reagent SystemJHS · Traditional | Coulter Electronics, Inc. | 12/30/1985SE |
| K843007 | Cardi-Ck Eia Test Kit Ck-Mb IsoenzymeJHS · Traditional | Intl. Immunoassay Laboratories, Inc. | 09/07/1984SE |
| K823211 | Ck-Uv ReagentJHS · Traditional | Biorent Diagnostic, Inc. | 11/22/1982SE |
| K820722 | Kodak Ektachem Clinical Chemistry SliddeJHS · Traditional | Eastman Kodak Company | 04/01/1982SE |
| K813406 | Cpk(Ck) in Vitro Diag. Reagent SetJHS · Traditional | Pointe Scientific, Inc., | 12/22/1981SE |
| K810997 | Worthington CK (Nac) Reagent SetJHS · Traditional | Worthington Diagnostic Systems | 04/23/1981SE |
| K803169 | Cardiozyme Plus Ck-Total #65046JHS · Traditional | Harleco | 01/09/1981SE |
| K802521 | Ck-Mb(Immunological)JHS · Traditional | Biodynamics Corp. | 11/12/1980SE |
| K801668 | Quick CeptJHS · Traditional | Laboratory Diagnostics Co., Inc. | 08/13/1980SE |
| K800028 | Worthington Flozyme* CPK (340NM)JHS · Traditional | Worthington Diagnostic Systems | 01/21/1980SE |
| K792023 | Eskachem, Ck-Mb ReagentJHS · Traditional | Smithkline Diagnostics, Inc. | 10/30/1979SE |
| K790918 | Esklab Reagent TabletsJHS · Traditional | Smithkline Diagnostics, Inc. | 06/22/1979SE |
| K790917 | Spin Chem Ck-Nac ReagentJHS · Traditional | Smithkline Diagnostics, Inc. | 06/22/1979SE |
| K790916 | Ck-Nuc ReagentJHS · Traditional | Smithkline Diagnostics, Inc. | 06/22/1979SE |
| K790343 | Data-Zyme CK Calorimetric/Uv ProcedureJHS · Traditional | Data Medical Associates, Inc. | 05/01/1979SE |
| K790088 | Aca Creatine Kinase IsoenzymesJHS · Traditional | E.I. Dupont DE Nemours & Co., Inc. | 03/12/1979SE |
| K790015 | Serum, Creatinine PhosphokinaseJHS · Traditional | Fisher Scientific Co., LLC | 02/15/1979SE |
| K781690 | L-Cysteine HydrochlorideJHS · Traditional | Fisher Scientific Co., LLC | 10/27/1978SE |
| K781432 | Stat Ultra Violet LiquidJHS · Traditional | Beckman Instruments, Inc. | 10/03/1978SE |
| K780504 | Creatine Phosphokinase (CPK)JHS · Traditional | Gamma Enterprises, Inc. | 05/03/1978SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-3187-2024 Class II | Creatine Kinase (CK) used on cobas c 311/501/502 and COBAS INTEGRA 400 plus-In vitro…Creatine Kinase (CK) Assay Abnormal calibrations on the cobas c 311/501/502 and COBAS INTEGRA 400 plus… | Roche Diagnostics Operations, Inc. | 08/15/2024Open, Classified |
| Z-0770-2021 Class II | VITROS Chemistry Products CKMB Slides: (1)VITROS CKMB Slides (60 Slide cartridge)…VITROS Chemistry Products CKMB Slides Potential for Falsely Elevated Results Due to CK-MM Interference | Ortho Clinical Diagnostics Inc | 12/11/2020Open, Classified |
| Z-1931-2020 Class II | VITROS Chemistry Products CKMB Slides, Creatine Kinase MB, Product Code 8001133-90…The Spanish and Swedish language versions of the IFU state that the assay can be tested with Plasma which is… | Ortho-Clinical Diagnostics | 04/01/2020Terminated |
| Z-1930-2020 Class II | VITROS Chemistry Products CKMB Slides, Creatine Kinase MB, Product Code 805 8232-300…The Spanish and Swedish language versions of the IFU state that the assay can be tested with Plasma which is… | Ortho-Clinical Diagnostics | 04/01/2020Terminated |
| Z-0117-2019 Class II | Atellica IM CKMB Master Curve Material, Cat No. 10995534 Product Usage: For in vitro…A potential bias was identified with certain kits compared to the internal standards. | Siemens Healthcare Diagnostics, Inc | 07/24/2018Terminated |
| Z-0116-2019 Class II | Atellica IM CKMB Calibrator, Cat No. 10995532 Product Usage: For in vitro diagnostic use…A potential bias was identified with certain kits compared to the internal standards. | Siemens Healthcare Diagnostics, Inc | 07/24/2018Terminated |
| Z-0115-2019 Class II | ADVIA Centaur CKMB Master Curve Material, Cat No. 07867768 Product Usage: For in vitro…A potential bias was identified with certain kits compared to the internal standards. | Siemens Healthcare Diagnostics, Inc | 07/24/2018Terminated |
| Z-0114-2019 Class II | ADVIA Centaur CKMB Calibrator 2-pack Japan, Cat No. 02562748 Product Usage: For in vitro…A potential bias was identified with certain kits compared to the internal standards. | Siemens Healthcare Diagnostics, Inc | 07/24/2018Terminated |
| Z-0113-2019 Class II | ADVIA Centaur CKMB Calibrator, Cat No. 09318028 Product Usage: For in vitro diagnostic…A potential bias was identified with certain kits compared to the internal standards. | Siemens Healthcare Diagnostics, Inc | 07/24/2018Terminated |
| Z-0306-2014 Class II | VITROS Chemistry Products CK-MB Slides packaged as 300 slides/pack catalog number…Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product… | Ortho-Clinical Diagnostics | 06/12/2013Terminated |
| Z-0305-2014 Class II | VITROS Chemistry Products CK Slides packaged as 300 slides/pack catalog number 8479396…Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product… | Ortho-Clinical Diagnostics | 06/12/2013Terminated |